FDA Advisory: Avoid Unintentional Exposure of Children and Pets to Evamist

/PRNewswire/ -- The U.S. Food and Drug Administration is warning that inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets.

Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. The FDA currently is reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product.

"Women using Evamist need to be aware of the potential risks to children who come in contact with the area of skin where this drug is applied," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III. "It is important that people know to keep both children and pets away from the product to minimize exposure."

Evamist was FDA approved in 2007. From July 2007 to June 2010, FDA received eight post-marketing cases of unintended exposure to Evamist in children ages 3 years to 5 years. Adverse events reported in unintentionally exposed children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males. Since 2007, two reports of secondary exposure to Evamist in dogs also have been received by FDA's Center for Veterinary Medicine. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling.

Patients using Evamist should not allow children to make contact with the area of the arm where Evamist is sprayed and should wash the child's skin with soap and water as soon as possible if contact does occur. Pets also should not be allowed to lick or touch the arm where Evamist is sprayed as small pets may be especially sensitive to the estrogen in this product. If direct contact with the arm where Evamist was sprayed cannot be avoided, it is recommended that women wear a garment that covers the area where the drug was applied.

At this time, it is unknown whether unintended exposure can occur with other topical estrogen products. The FDA is continuing to review adverse event reports and evaluate ways to reduce unintended exposures to these products.

Consumers and health care professionals should report any side effects from Evamist by using the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

-----
Community News You Can Use
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Dangerous Contraceptive Drug Yaz and Yasmine Raise Serious Health Risks

Some women may have sustained serious injury after taking contraceptives under the names "Yaz" "Yasmin" or "Ocella." Use of the drug may cause strokes, heart attacks, DVT (blood clots in legs), Pulmonary Embolism (blood clots in lungs, and dehydration, leading to kidney stones or gall bladder disease.

What is Yaz?
Yasmin and Yaz are contraceptive drugs produced by Bayer Healthcare. Yasmin and Yaz are known as "fourth generation" combination oral birth control drugs because they contain a combination of the hormones estrogen (ethinyl estradiol) and progestin (drospirenone). Yasmin was approved for use in the United States in 2001, while Yaz, a lower dose version, was approved for use in 2006. It is marketed under the name Ocella as a generic brand. The difference between Yaz and Yasmine is in the amount of the estrogen component, ethinyl estradiol. Yasmin contains 30 mcg ethinyl estradiol, while Yaz contains a lower dose of 20 mcg. This contraceptive is one of the most popular contraceptives and has been heavily marketed to women throughout the United States promoting its use in treating premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD).

Why is Yaz dangerous?
There are several reasons.

Dehydration. This key ingredient Drospirenone may cause dehydration and then increase potassium levels in the blood, which, according to the Food and Drug Administration (FDA), can be dangerous. Dehydration can lead to kidney stones and gallbladder disease.

Heart Problems. Potassium acts as a critical control in cardiac rhythm. Because of that, this imbalance can cause heart rhythm disturbances. This process can result in a stroke, heart attack, the formation of blood clots, deep vein thrombosis (DVT), pulmonary embolism, and even death.

Blood clot conditions including DVT and Pulmonary Embolism are serious Yaz side effect reported by women using this fourth-generation birth control pill. Many women with no family history of blood clots have suffered from life threatening injuries involving clots. The type of hormones in birth control pills can increase the risk of developing blood clots which can lead to serious problems especially if they are not diagnosed early.

After having a blood clot many women are then faced with life-changing side effects including being on blood thinners, pain in the area of the clot, and increased risk of developing another clot.

One of the more serious conditions reported by women who used Yaz or Yasmine are strokes. There are two main types of strokes: ischemic stroke (caused by blockage) and hemorrhagic stroke (caused by bleeding). Women who are otherwise healthy with no prior stroke problems have experienced a stroke where no other health issues exist. After having a stroke many women are then faced with life-changing side effects including permanent loss of movement, difficulty communicating and permanent loss of brain functions.

Quality Control. Recently, the FDA has taken action against Bayer to limit the drug's entry into the nation from Germany where it is manufactured citing serious quality control issues.

Has Bayer Properly Warned You About the Risks?
Bayer has also been cited by the FDA for overstating the benefits of Yaz and understating the risks in taking the contraceptive in its marketing of the drug. As part of an agreement with the FDA and more than two dozen state legal officials, Bayer was pressured into removing the ads, but is still marketing the drug with a new ad campaign which started early in 2009. "Those products were the company's top-selling pharmaceuticals last year, with global sales of $1.8 billion," according to The New York Times.

Article provided by Marcus & Mack

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page